AccessGUDID - DEVICE: Trucise® 2.0 Total System (05020583300088)

GUDID

Device Identifier (DI) Information

Brand Name: Trucise® 2.0 Total System
Version or Model: METCM2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TERUMO BCT, INC.

Primary DI Number: 05020583300088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801679200 *Terms of Use

Device Description: Trucise 2.0 Communication Module

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36149	Blood bank information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, and/or distribute administrative and/or clinical data within blood-bank centres. Specific functions typically include management of blood-donor data, autologous and direct blood unit tracking (e.g., using radio-frequency identification (RFID)], and/or cross-match result determination. It consists of dedicated combined hardware (e.g., computers, terminals, network components, blood unit containers) and software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSB	SET, TRANSFER (BLOOD/PLASMA)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK110071	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cdd3d404-8778-4b7f-87a6-da576b420d97
Public Version Date: July 24, 2023
Public Version Number: 7
DI Record Publish Date: September 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)339-4228
Email: FDAUDIprogram@terumobct.com

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